Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) pain intensity scores through 7 days (168 hours) for participants receiving Exparel vs. R.E.C.K.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
详细描述
Intra-op opioid administration will be collected and recorded for each participant via EMR review. While in the post anesthesia care unit and the remainder of the inpatient stay, the following will be assessed and captured: pain score via Numerical Rating Score (NRS) captured per standard of care, oral and IV opioid intake, and length of inpatient stay.
After discharge, the participants will be asked to record and timestamp the following in a provided take-home paper diary: pain via NRS in response to the prompt "How much pain are you experiencing right now?" and self-administered medications and dose (ibuprofen, acetaminophen, naproxen, and opioids) throughout the day.
Treatment will be administered intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign an IRB-approved informed consent
- •Age ≥ 18 years at the time of consent.
- •Planned robotic partial or radical nephrectomy
排除标准
- •Determined not to be a candidate to receive R.E.C.K or Exparel per the enrolling investigator
- •Known pregnancy
- •Chronic opioid use within 30 days (as per patient report) prior to randomization (defined as ≥ 30 MME/day)
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator.
- •Known allergy to R.E.C.K. and/or Exparel
研究组 & 干预措施
Arm B
Intraoperative Exparel
干预措施: Exparel (Drug)
Arm A
Intraoperative R.E.C.K.
干预措施: Ropivacaine HCL (Drug)
Arm A
Intraoperative R.E.C.K.
干预措施: Clonidine HCL (Drug)
Arm A
Intraoperative R.E.C.K.
干预措施: Ketorolac (Drug)
Arm A
Intraoperative R.E.C.K.
干预措施: Epinephrine (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) pain intensity scores through 7 days (168 hours) for participants receiving Exparel vs. R.E.C.K.
时间窗: Day of Surgery to Day 7 Post-Surgery
Assess pain intensity (evaluated by NRS) after surgery on the as response to the prompt: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?" The AUC will be derived for each participant from self-reported pain scores and will be summarized by treatment group. Generalized linear models with main effect of treatment will be estimated to test for significant differences in AUC between the arms.
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) pain intensity scores through 7 days (168 hours) for participants receiving Exparel vs. R.E.C.K.
时间窗: Day of Surgery to Day 7 Post-Surgery
Assess pain intensity (evaluated by NRS) after surgery on the as response to the prompt: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?" The AUC will be derived for each participant from self-reported pain scores and will be summarized by treatment group. Generalized linear models with main effect of treatment will be estimated to test for significant differences in AUC between the arms.
次要结局
- Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 7 Post-Surgery)
- Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K.(Day of Surgery to Day 30 Post-Surgery)